Status:
COMPLETED
Improving the Frequency and Quality of Sleep Apnea Care Management
Lead Sponsor:
VA Office of Research and Development
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
OSA is a major chronic condition affecting the quality of life of millions of Americans. Per the Institute of Medicine new treatment adherence strategies are needed to help improve the quality of care...
Detailed Description
The objective of this proposal is to evaluate a new mobile health (mHealth) system for patients with Obstructive Sleep Apnea syndrome (OSA) that facilitates patient-centered, collaborative management ...
Eligibility Criteria
Inclusion
- The project will have a 4-year timeline. Patients and providers at both the VA Pulmonary Sleep Clinic will participate in this prospective randomized clinical trial. Patients will participate by completing written informed consent, agreeing to be randomized, completing a baseline assessment, participating in the study interventional protocol, and completing follow-up assessments up to one-year post-intervention. The intent is to recruit a study population that is fairly representative of the overall VASDHS population of patients diagnosed with OSA. To this end, inclusion criteria are designed to be as inclusive as possible and are operationalized as follows:
- age \> 18 years;
- confirmed diagnosis of OSA;
- being newly prescribed CPAP therapy; and
- having chronic symptoms as noted on screening symptom checklist. OSA diagnosis by the Sleep Clinic has been and is currently consistent with published consensus statements49 that CPAP treatment is indicated when the apnea-hypopnea index (AHI, number of apneas + hypopneas per hour of sleep) is either (1) greater than or equal to 15, or (2) between 5 and 15 AND accompanied by documented sleep apnea symptoms, including excessive daytime sleepiness, impaired cognition, mood disorders, insomnia, and documented cardiovascular diseases. Because mild OSA symptoms are at best modestly correlated with AHI, the research study will focus on patients with moderate to severe sleep apnea, and therefore inclusion criteria will require AHI \> 15.
Exclusion
- Exclusion criteria include cognitive impairment sufficient to cause inability to complete the protocol (MMSE \< 24/30);
- residence in a geographical area outside of San Diego County (which could make some necessary face-to-face contact difficult);
- fatal comorbidity (life expectancy less than 6 months as indicated by treating physician);
- significant documented substance/chemical abuse; or
- other participant circumstances that, in the opinion of a consensus of study team, would interfere with the safety of a prospective participant or their need for treatment (i.e., clinical needs of patient outweighs needs of research study). No exclusion criteria or any other study design elements will be used directly or indirectly to restrict study participation by women, members of minority groups, or primary language. Because men have a greater risk for OSA (and are identified and diagnosed at a greater rate) than women, we anticipate a final sample that reflects the OSA base rate differences on sex. Some minority groups are thought to have higher OSA prevalence rates than Caucasians, so assuming they are being screened/diagnosed at the same rates as Caucasians, we expect minority groups to be included in the study at levels that reflect those rates.
Key Trial Info
Start Date :
August 3 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2018
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT01916655
Start Date
August 3 2015
End Date
March 30 2018
Last Update
September 6 2019
Active Locations (1)
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1
VA San Diego Healthcare System, San Diego, CA
San Diego, California, United States, 92161